ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
Report
- Report Number
- 3001845648-2018-00284
- Event Type
- Malfunction
- Date Received
- June 25, 2018
- Date of Event
- May 28, 2018
- Report Date
- June 28, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002353166
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
PMA #P100022/S014. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PROBLEM STATEMENT "AFTER APPROPRIATE PRE-DEPLOYMENT MEASUREMENTS AND DEVICE PREPARATION, THE DOCTOR NOTICED THE 7MMX120MM ZILVER PTX STENT WAS SHORTENING WHILE BEING DEPLOYED. POST-DILATION WITH A 6MMX120MM EV3 BALLOON CONFIRMED THAT THE SHORTENING WAS IN THE RANGE OF 20MM. WHILE THE STENT DIDN'T COVER THE DESIRED VESSEL SEGMENT, NO ADDITIONAL PROCEDURE WAS REQUIRED." DEVICE EVALUATION THE ZISV6-35-80-7.0-120-PTX DEVICE OF LOT NUMBER C1318053 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: IMAGE REVIEW IS THE COMPLAINT CONFIRMED? YES. OBSERVATION OF DEVICE EFFECTS, RELATIVE TO THE PATIENT'S ANATOMY: NONE. OBSERVATION OF DEVICE EFFECTS, RELATIVE TO THE DISEASE STATE: NONE. OBSERVATION OF SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE: NONE. OBSERVATION OF ADDITIONAL DEVICE FINDINGS RELATIVE TO THE CLINICAL PERSPECTIVE: NONE OTHER (AS REQUESTED IN COMPLAINT REVIEW INTAKE FORM): NONE. FINDINGS: 1. A SINGLE IMAGE OF THE LEFT SFA STENT IS PROVIDED ALONG WITH THE COMPLAINT REPORT. 2. THE IMAGE DEMONSTRATES THE STENT WITH THE POST IMPLANTATION 7X120MM BALLOON FULLY INFLATED INSIDE. THE STENT MEASURED 105MM. CONTRAST IN THE BALLOON OBSCURED DETAIL OF THE STENT. THE LESION WAS MILDLY CALCIFIED. 3. THE COMPLAINT REPORTS LISTS THE OTHER DEVICES USED DURING THE CASE. THE USE OF A SHORT 6F SHEATH INDICATES THAT ACCESS WAS ANTEGRADE THROUGH THE IPSILATERAL COMMON FEMORAL ARTERY. IMPRESSION THE STENT WAS IMPLANTED IN THE MID DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA) FROM AN IPSILATERAL COMMON FEMORAL ARTERY ANTEGRADE APPROACH. THIS LIKELY PLACED THE STABILITY SHEATH OUTSIDE THE ACCESS SHEATH. UPON DEPLOYMENT, IF THE HANDLE WAS NOT RIGIDLY FIXED OR EVEN PLACED UNDER SOME RETRACTION PRESSURE, THE RETRACTION SHEATH WOULD PULL THE HANDLE, INNER CATHETER, AND STENT DEEPER INTO THE ARTERY. THIS WOULD BE NOTICEABLE ON FLUOROSCOPIC OBSERVATION AND PROMPT THE OPERATOR TO LIMIT THE ADVANCEMENT BY APPLYING RETRACTILE PRESSURE ON THE ENTIRE DEVICE. HOWEVER GIVEN THE INHERENT TIME DELAY AND PLAY IN THE LONG CATHETER, MODEST LONGITUDINAL COMPRESSION, SUCH AS THE 15% IN THIS CASE, IS UNDERSTANDABLE. THE CUSTOMER WAS CONTACTED TO REQUEST ADDITIONAL INFORMATION HOWEVER, NO REPLIES WERE RECEIVED. THE INVESTIGATION WILL BE UPDATED IF THE INFORMATION IS LATER PROVIDED. THE COMPLAINT IS CONFIRMED AS MODEST LONGITUDINAL COMPRESSION WAS OBSERVED IN THE IMAGING REVIEW. ROOT CAUSE POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE A DIFFICULT ANATOMY, WHICH COULD HAVE APPLIED FORCES TO THE STENT, AND CAUSED OR CONTRIBUTED TO THE STENT SHORTENING DURING DEPLOYMENT. FROM THE IMAGE REVIEW THE FOLLOWING POSSIBLE ROOT CAUSE WAS IDENTIFIED; ¿THE STENT WAS IMPLANTED IN THE MID DISTAL LEFT SFA FROM AN IPSILATERAL COMMON FEMORAL ARTERY ANTEGRADE APPROACH. THIS LIKELY PLACED THE STABILITY SHEATH OUTSIDE THE ACCESS SHEATH. UPON DEPLOYMENT, IF THE HANDLE WAS NOT RIGIDLY FIXED OR EVEN PLACED UNDER SOME RETRACTION PRESSURE, THE RETRACTION SHEATH WOULD PULL THE HANDLE, INNER CATHETER, AND STENT DEEPER INTO THE ARTERY. THIS WOULD BE NOTICEABLE ON FLUOROSCOPIC OBSERVATION AND PROMPT THE OPERATOR TO LIMIT THE ADVANCEMENT BY APPLYING RETRACTILE PRESSURE ON THE ENTIRE DEVICE. HOWEVER GIVEN THE INHERENT TIME DELAY AND PLAY IN THE LONG CATHETER, MODEST LONGITUDINAL COMPRESSION, SUCH AS THE 15% IN THIS CASE, IS UNDERSTANDABLE.¿ HOWEVER, THE DEVICE IS NOT AVAILABLE FOR EVALUATION, THE INFORMATION REQUESTED HAS NOT YET BEEN PROVIDED AND THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT. THEREFORE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. DOCUMENT REVIEW ZISV6-35-80-7.0-120-PTX DEVICE OF LOT NUMBER C1318053 CONTAINS ZVSP6-T-35-80-7.0-120-IS (ZILVER PTX) OF LOT CH1278145. A REVIEW OF INCOMING QC RECORDS DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1318053. SUMMARY THE COMPLAINT IS CONFIRMED AS MODEST LONGITUDINAL COMPRESSION WAS OBSERVED IN THE IMAGING REVIEW. THE RISK ASSOCIATED WITH THIS COMPLAINT IS RISK CATEGORY III (LOW). ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA #P100022/S014. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA #P100022/S014. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. PROBLEM STATEMENT: "AFTER APPROPRIATE PRE-DEPLOYMENT MEASUREMENTS AND DEVICE PREPARATION, THE DOCTOR NOTICED THE 7MMX120MM ZILVER PTX STENT WAS SHORTENING WHILE BEING DEPLOYED. POST-DILATION WITH A 6MMX120MM EV3 BALLOON CONFIRMED THAT THE SHORTENING WAS IN THE RANGE OF 20MM. WHILE THE STENT DIDN'T COVER THE DESIRED VESSEL SEGMENT, NO ADDITIONAL PROCEDURE WAS REQUIRED." DEVICE EVALUATION: THE ZISV6-35-80-7.0-120-PTX DEVICE INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. IMAGES OF THE DEVICE WERE PROVIDED. THE INVESTIGATION WILL BE UPDATED ONCE THE IMAGES HAVE BEEN REVIEWED. THE CUSTOMER WAS CONTACTED TO REQUEST ADDITIONAL INFORMATION. THE INVESTIGATION WILL BE UPDATED ONCE THE INFORMATION HAS BEEN PROVIDED. THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE A DIFFICULT ANATOMY, WHICH COULD HAVE APPLIED FORCES TO THE STENT, AND CAUSED OR CONTRIBUTED TO THE STENT SHORTENING DURING DEPLOYMENT. HOWEVER, THE DEVICE IS NOT AVAILABLE TO EVALUATED, THE IMAGES HAVE NOT YET BEEN REVIEWED, THE INFORMATION HAS NOT YET BEEN PROVIDED AND THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT. THEREFORE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0117-2). AS PER THE PRODUCT INSTRUCTION FOR USE:¿THE ZILVER PTX DRUG-ELUTING PERIPHERAL STENT IS DESIGNED NOT TO SHORTEN ON DEPLOYMENT.¿ DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY AS PER FQC. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS (C1318053, CH1278145) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH THIS LOT NUMBER. SUMMARY: THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE RISK WILL BE ASSESSED FOR THIS COMPLAINT ONCE THE IMAGES ARE EVALUATED. WHEN THE RISK HAS BEEN ASSESSED THE INVESTIGATION WILL BE UPDATED WITH THE RISK DETAILS. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
REPORT IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: 'DEPLOYMENT ISSUE THAT RESULTS IN THE EXPOSED STENT REMOVED FROM THE PATIENT WITH THE DELIVERY SYSTEM' AFTER APPROPRIATE PRE-DEPLOYMENT MEASUREMENTS AND DEVICE PREPARATION, THE DOCTOR NOTICED THE 7MMX120MM ZILVER PTX STENT WAS SHORTENING WHILE BEING DEPLOYED. POST-DILATION WITH A 6MMX120MM EV3 BALLOON CONFIRMED THAT THE SHORTENING WAS IN THE RANGE OF 20MM. PHOTO ATTACHED. WHILE THE STENT DIDN'T COVER THE DESIRED VESSEL SEGMENT, NO ADDITIONAL PROCEDURE WAS REQUIRED.
REPORT IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: 'DEPLOYMENT ISSUE THAT RESULTS IN THE EXPOSED STENT REMOVED FROM THE PATIENT WITH THE DELIVERY SYSTEM' AFTER APPROPRIATE PRE-DEPLOYMENT MEASUREMENTS AND DEVICE PREPARATION, THE DOCTOR NOTICED THE 7MMX120MM ZILVER PTX STENT WAS SHORTENING WHILE BEING DEPLOYED. POST-DILATION WITH A 6MMX120MM EV3 BALLOON CONFIRMED THAT THE SHORTENING WAS IN THE RANGE OF 20MM. PHOTO ATTACHED. WHILE THE STENT DIDN'T COVER THE DESIRED VESSEL SEGMENT, NO ADDITIONAL PROCEDURE WAS REQUIRED.
INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: 'DEPLOYMENT ISSUE THAT RESULTS IN THE EXPOSED STENT REMOVED FROM THE PATIENT WITH THE DELIVERY SYSTEM' AFTER APPROPRIATE PRE-DEPLOYMENT MEASUREMENTS AND DEVICE PREPARATION, THE DOCTOR NOTICED THE 7MMX120MM ZILVER PTX STENT WAS SHORTENING WHILE BEING DEPLOYED. POST-DILATION WITH A 6MMX120MM EV3 BALLOON CONFIRMED THAT THE SHORTENING WAS IN THE RANGE OF 20MM. WHILE THE STENT DIDN'T COVER THE DESIRED VESSEL SEGMENT, NO ADDITIONAL PROCEDURE WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 476534 | ZILVER PTX DRUG-ELUTING PERIPHERAL STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | C1318053 | 10827002353166 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |